The use of enzyme immunoassays to screen for toxins A and B produced by Clostridium difficile is a common procedure in algorithms designed for its detection. Moreover, the absence of a unique test capable of providing reliable results at low cost motivates a great discussion about which algorithm is the best. Thus, several studies have evaluated the performance of these enzyme immunoassays. However, all fail to provide sufficient explanations for the different behaviours observed in different studies that evaluate the same index test against a common reference method. Our main goal was to find out which factors affect the sensitivity of these assays, since the specificity is very close to 1. In this research, we verified that sensitivity increases with the prevalence rate and with the proportion of reported cases of onset diarrhea. Therefore, its use is advisable for high prevalence rates (e.g. in an epidemic setting). As far as reference methods are concerned, nucleic acid amplification tests can be used as a reference method, with a performance similar to the well-accepted toxigenic culture. The method chosen for toxigenicity screening in a toxigenic culture also seems to affect the evaluation performance of tests and should be better studied in the future.

中文翻译：

---

参考方法对艰难梭菌免疫测定灵敏度的影响：荟萃分析。

在针对其检测而设计的算法中，使用酶免疫分析法筛选艰难梭菌产生的毒素A和B是一种常见程序。此外，缺少能够以低成本提供可靠结果的独特测试，引发了关于哪种算法最好的讨论。因此，一些研究评估了这些酶免疫测定的性能。但是，所有这些都无法为在不同研究中观察到的不同行为提供充分的解释，这些研究针对相同的参考方法评估相同的指标测试。因为特异性非常接近1，所以我们的主要目标是找出哪些因素会影响这些测定的灵敏度。在这项研究中，我们验证了灵敏度随患病率和报告的腹泻发病率的增加而增加。因此，建议将其用于较高的流行率（例如在流行环境中）。就参考方法而言，核酸扩增试验可以用作参考方法，其性能与公认的产毒培养物相似。在有毒细菌培养物中选择有毒物质进行筛选的方法似乎也影响测试的评估性能，将来应进行更好的研究。